Cambrex  

East Rutherford,  NJ 
United States
https://www.cambrex.com/
  • Booth: 613

Cambrex is an innovative life sciences company that provides pharmaceutical products, expertise and technologies that accelerate small molecule therapeutics into markets across the world.

With over 35 years of API development and manufacturing expertise, Cambrex is tried and trusted across branded and generic API markets.


 Press Releases

  • East Rutherford, NJ – January 16, 2018 – Cambrex Corporation (NYSE: CBM), the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), today held an opening ceremony with AstraZeneca, at its Karlskoga, Sweden site to mark the commencement of a long-term manufacturing agreement between the two companies for a key intermediate.

    Pictured: The Cambrex and AstraZeneca teams at the opening ceremony

    The announcement follows the completion, in 2017, of both a large-scale, multi-purpose capacity expansion which also includes hydrogenation capabilities and a dedicated continuous flow production unit capable of producing multiple metric tons of high purity advanced intermediates per annum at the Karlskoga facility.

    Speaking at the ceremony, Juliette White, VP Global External Sourcing, AstraZeneca, commented, “Cambrex was selected as our manufacturing partner on this long-term intermediate supply agreement as they clearly demonstrated a robust technically and commercially attractive solution, as well as having a good track record in terms of performance and delivery.” She added, “We look forward to a successful collaboration with Cambrex.”

    Shawn Cavanagh, COO of Cambrex, stated, “We have an excellent relationship with AstraZeneca dating back to the 1950s and are excited to partner with them on the long-term production of several important products.” He added, “We will continue to invest in capabilities, technology and appropriate capacity at the Karlskoga site in line with AstraZeneca’s ambitious targets and on-going customer demand.”

  • East Rutherford, NJ – January 30, 2018 – Cambrex Corporation (NYSE: CBM), the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), today announced an investment to expand chemical and analytical development capabilities at its Charles City, Iowa plant. The project forms part of the company’s strategic plan to increase its development capacity and resources in North America.

    The expansion will see the construction of an additional 2,000 sq.ft. of laboratory space for development projects, and will support the hiring of an additional 14 chemists. The building, installation and validation of equipment is expected to be completed by Q1 2018.

    The expansion at Charles City is in parallel to the investments announced in 2017 at Cambrex’s facility in High Point, North Carolina, where a new 11,000 sq.ft. analytical laboratory and 400 sq.ft. pilot plant with a total reactor capacity of 4,000 liters are currently being completed. These expansions at High Point will create up to 18 new jobs.

    “The Charles City site has seen multiple investments and expansions in manufacturing capacity over the past five years to meet market demand, and this in turn, has led to us needing to increase the capacity of the supporting development and analytical functions,” commented Joe Nettleton, Vice President US Operations, Cambrex. “Our strategy in expanding the development capabilities across the sites at both Charles City and High Point is to ensure both facilities are harmonized and can function synergistically so that projects can be seamlessly transferred between the two.”

    Cambrex’s Charles City, Iowa facility is located on a 45-acre site and manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances. The High Point site, formerly PharmaCore, Inc., was acquired by Cambrex in October 2016, and produces complex APIs and intermediates in batch sizes from milligrams to 100kg to support clinical trials from Phase I to Phase III.


 Products

  • Custom Development
    We offer our customers a truly end-to-end partnership for the research, development and manufacture of their small molecule APIs at every stage of the lifecycle....

  • Our experienced team are here to deliver your custom development projects on time, within budget and to the highest quality standards. We have the expertise, flexibility and resources to provide a full range of custom development services designed to meet your project needs.


    Our API custom development services include:
    •  Route selection

    •  Process development and optimization (early to late stage, small to large scale)

    •  Analytical development and validation

    •  Synthesis and purification of analytical reference standards

    •  ICH stability studies

    •  Safety and toxicology assessments

    •  Controlled substances R&D
     

  • Custom Manufacturing
    We offer our customers a truly end-to-end partnership for the research, development and manufacture of their small molecule APIs at every stage of the lifecycle.
    ...

  • With a focus on quality, innovation and flexibility, we offer manufacturing excellence across our global network. Our extensive manufacturing capabilities allow us to take your project from development to scale-up and commercial production.


    Our API cGMP custom manufacturing services include:
    •  Process and analytical validation

    •  Kilo scale, pilot scale and commercial manufacturing for clinical and commercial supply

    •  Quality Assurance and Quality Control

    •  Regulatory support and filings

  • Generic APIs
    We are a leading global supplier of generic APIs. From our sites in Italy, Sweden and the USA, we work with generic drug companies well in advance of drug patent expiration, using high quality, non-patent infringing processes to manufacture APIs.
    ...

  • Our generic API manufacturing and development capabilities include:

    • Leading range of more than 100 generic APIs; 90 of which are commercially sold and free from patent
    • Around 30 APIs in different phases, from under development to fully validated
    • 90 Drug Master Files (DMFs) filed globally
    • Development and process optimization
    • Support for New Drug Applications (NDAs) and 505B2 NDAs for existing APIs
    • Commercial scale cGMP manufacturing
    • Strong regulatory performance with regulatory agencies around the world (FDA, PMDA, ANVISA, KFDA and AIFA to name a few)
  • High Energy Chemistry
    We offer world-class expertise in energetic chemistry combined with quality cGMP capabilities. Cambrex can provide thermal and process safety studies to support manufacturing at our facilities or on a consultancy basis....

  • Manufacturing Capabilities

    • High energy APIs

    • High energy intermediates

    • Nitration with Nitric Acid

    • Catalytic hydrogenation

    • Oxidation with Nitric Acid

    • Oxidation with Hydrogen Peroxide

    • Diazotization with Sodium Nitrite

    • Grignard, formation and reaction

    • Organic Azide formation with Sodium Azide

    • Reduction with LiAIH4

    • Lithiation with BuLi/HexLi

    • Hydroxylamine, HCl as reagent

  • Controlled Substances
    Cambrex has held US Drug Enforcement Agency (DEA) licenses for process research, development, manufacturing and importation of Schedule II-V controlled substances for >15 years....

  • Development, manufacture and distribution of controlled substances

    We are one of a limited number of US companies authorized by the DEA to import narcotic raw materials  at commercial scale and have been successfully manufacturing highly potent opioids since 2005.

    •  Routinely manufacture and distribute commercial quantities of  Schedule II-V controlled substances throughout the world

    •  Drug Master Files (DMF) for >20 controlled substances

    •  Controlled substances R&D

  • High Potency APIs
    We have been reliably developing and manufacturing high potency APIs and compounds for more than 15 years....

  • High Potent APIs manufacturing capabilities
    • Highly regimented safety protocols

    • Controlled access to all areas

    • Best-in-class barrier isolation

         - Process development     

         -  Scale-up of toxicology lot to commercial quantities in a cGMP environment     

         -  Development and manufacturing of HPAPIs and intermediates to 0.01 μg/m3       

         -  Lab scale cGMP manufacturing up to 20L

    • cGMP kilo lab up to 150L

    • cGMP pilot plant

    • Commercial manufacturing up to 16,000L

    • Multi-purpose solids handling suite

    • cGMP micronization facility

  • Biocatalysis
    Cambrex has >15 years’ experience in developing and commercially manufacturing APIs, intermediates and bulk chemicals using biocatalysis....

  • Biocatalysis provides for efficient and environmentally friendly commercial scale manufacturing through enzymatic synthesis and provides pure -regio, chemo- and enantioselective compounds when compared to traditional chemical synthesis. Our team of experts can design, optimize and provide R&D screening services using the Cambrex proprietary library of 600 enzymes.


    • Enzyme screening

    • Enzyme development  

          - Cloning and gene discovery  

          -  Characterization and description of genes for different enzymes and functions  

          - Using different expression systems

    •  Process development and enzyme manufacture  

          -  Ability to work with different organisms and enzymes  

          -  Process know-how for industrial enzyme production  

          -  Process optimization and technology transfer available